Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001461785
Ethics application status
Approved
Date submitted
14/10/2022
Date registered
17/11/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
17/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Autonomic nervous system response to six weeks of chiropractic care.
Scientific title
Autonomic nervous system responses to six weeks of chiropractic care in people with subclinical pain: A pragmatic pilot randomised controlled trial.
Secondary ID [1] 308229 0
none
Universal Trial Number (UTN)
U1111-1274-5388
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autonomic Nervous System Function 327927 0
Condition category
Condition code
Alternative and Complementary Medicine 324995 324995 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
- At each visit, a spinal exam, including active and passive range of motion, palpation, and muscle testing if required, will be performed to determine the location of spinal dysfunction(s) by qualified chiropractors. Techniques used for their correction will include high-velocity low- amplitude, table-assisted and instrument-assisted approaches. Participants will also receive personalised postural advice and stretches (which could include: spinal range of motion of the cervical, thoracic and lumbar regions; stretches for the hamstring, hip flexors, gluteus Maximus, pectoralis major, child’s pose, etc) to carry out at home. The frequency of care is set to be 12 visits over 6 weeks.

Anticipated duration:
- Intervention session (1st= 30min, following= 10-15min)

Continuous measures (wearable device):
- Participants will each be given a wearable device (Fitbit 3) at the initial session and explain how it works. They will be instructed to keep wearing it most of the day and night during the 6 weeks of the intervention. Sleep efficiency, short-term HRV and physical activity will be extracted at the end of the intervention period.




Intervention code [1] 324636 0
Treatment: Other
Comparator / control treatment
Baseline and post-intervention assessments, duration of sessions and fidelity measures are the same than the intervention group.

Control will be provided by the same chiropractors as the intervention. Study participants will attend six visits over six weeks, and will receive the same spinal exam and personalised postural advice and stretches. No spinal adjustment will be performed. Participants will also be provided with spinal exercises to carry out at home. Examples of spinal exercises includes various cervical, thoracic and lumbar range of motion, 'child pose', 'cat and cow' stretches, hip flexors stretches, etc.
Control group
Active

Outcomes
Primary outcome [1] 333043 0
Primary outcome 1:
- Recruitment feasibility: Ten participants recruited within the first two months to be part of Cycle 1 and ten more participants recruited during the following six weeks to be part of Cycle 2. The number of people screened and the eligibility for inclusion will be recorded and use to evaluate recruitment rate.
Timepoint [1] 333043 0
Primary outcome 1: 12 weeks post-intervention commencement. .
Primary outcome [2] 333044 0
Primary outcome 2:
- Retention feasibility: Drop-outs do not exceed 20% in the intervention or control groups. Evaluated through sessions records, matching of enrolment log and post-intervention assessment log. Drop-outs and their reasons, if provided, will also be recorded during the intervention.
Timepoint [2] 333044 0
Primary outcome 2: 12 weeks post-intervention commencement.
Primary outcome [3] 333047 0
Primary outcome 3:
- Data completeness feasibility: At least 90% of planned outcome measurements are recorded for the baseline and post-intervention measurements. For the wearable device, the aim is to achieve at least 70% of usable data. The number of planned outcome measurements that are usable will be calculated. and data completeness will be evaluated through the analysis of usable data.
Timepoint [3] 333047 0
Primary outcome 3: post-intervention completion and after analysis of raw data, aiming to be done within 3-months post-intervention assessment.
Secondary outcome [1] 414752 0
Primary outcome 4:
- Safety: Participants will be asked at the start of each session if they have experienced any adverse events or adverse treatment effects and these will be recorded on an adverse event form. Moderate to severe adverse events are not expected during this study as their occurence is rare but could include migraine, sprain-strain or fractured ribs.
Timepoint [1] 414752 0
Primary outcome 4: ongoing monitoring from intervention commencement to 12 weeks post-intervention commencement.
Secondary outcome [2] 415605 0
Primary outcome 5:
- Adherence to intervention or control sessions: Participants attend at least 80% of all scheduled sessions as per the protocol. Evaluated through auditing of sessions' records.
Timepoint [2] 415605 0
Primary outcome 5: 12 weeks post-intervention commencement.
Secondary outcome [3] 415606 0
Primary outcome 6:
- Intervention fidelity: At least 80% of the intervention and control is provided as per the protocol. Evaluated through auditing of sessions' records.
Timepoint [3] 415606 0
Primary outcome 6: 12 weeks post-intervention commencement.
Secondary outcome [4] 415812 0
Secondary outcome 1:
- Autonomic nervous system (ANS) measures:
1.a. Short term Heart rate variability (HRV) measured using photoplethysmography (CLA device) at pre- and post- intervention assessments (assessing mean interbeat interval (IBI), Standard deviation of the NN intervals (SDNN), Root mean square of the successive differences (RMSSD), low-frequency (LF), high-frequency (HF), normalised LF (%), normalised HF (%), LF/HF ratio, total power).
Timepoint [4] 415812 0
Secondary outcome 1: Pre and post-intervention assessment (week 0 and weeks 6 of each cycle)
Secondary outcome [5] 415813 0
Secondary outcome 2:
- Autonomic nervous system (ANS) measures:
1.b. Galvanic skin response (GSR) measured at pre- and post-intervention assessments (CLA device) (recording skin conductance at a sampling rate of 1-10Hz and measured in micro-Siemens (µS) units).
Timepoint [5] 415813 0
Secondary outcome 2: Pre and post-intervention assessment (week 0 and weeks 6 of each cycle)
Secondary outcome [6] 415814 0
Secondary outcome 3:
- Autonomic nervous system (ANS) measures:
1.c. Pupillometry measured with a computerised eye tracker (Tobii 5) at pre- and post-intervention assessments and midpoint (recording contraction time and velocity, amplitude, re-dilatation velocity, pupil size, and latency time).
Timepoint [6] 415814 0
Secondary outcome 3: Pre and post-intervention assessment (week 0 and weeks 6 of each cycle) and at the midpoint (week 3 of each cycle).
Secondary outcome [7] 415815 0
Secondary outcome 4:
- Autonomic nervous system (ANS) measures:
1.d. Functional near infra red spectroscopy (fNIRS) (prefrontal cortex) before, during and after cold pressor test, at pre- and post- intervention assessments.
Timepoint [7] 415815 0
Secondary outcome 4: Pre and post-intervention assessment (week 0 and weeks 6 of each cycle)
Secondary outcome [8] 415816 0
Secondary outcome 5:
- Continuous ANS measure (wearable Fitbit 3 device)
2.a. Sleep efficiency
Timepoint [8] 415816 0
Secondary outcome 5: continuous during the length of the intervention.
Secondary outcome [9] 415817 0
Secondary outcome 6:
- Continuous ANS measure (wearable Fitbit 3 device)
2.b. short-term HRV
Timepoint [9] 415817 0
Secondary outcome 6: continuous during the length of the intervention.
Secondary outcome [10] 415818 0
Secondary outcome 7:
- Continuous ANS measure (wearable Fitbit 3 device)
2.c. physical activity
Timepoint [10] 415818 0
Secondary outcome 7: continuous during the length of the intervention.

Eligibility
Key inclusion criteria
- Aged 18-65 years.
- Not actively managing any acute or chronic pain.
- Subclinical spinal-related pain (as defined by having recurrent intermittent episodes of pain or tension related to different spinal areas mild enough that participants have not yet sought treatment for and that is grade 3 or under of the Chronic Pain Grade Scale (CPGS) at the time of recruitment
- Physically active (category 2 or 3 on the International Physical Activity Questionnaire excluding participants engaging in more than 5000 MET (metabolic equivalent) per week)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to chiropractic care (such as the history of recent fractures; high blood pressure; and metabolic, inflammatory, or neoplastic disease).
- Pupillary abnormalities or damage (i.e., coloboma or oculomotor palsy), or enucleation of the eye.
- Diagnosed dysautonomia and Raynaud’s disease.
- Taking daily medication with the exception being the contraceptive pill.
- Immunization planned during the 6 weeks intervention period.
- Smoking.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
30/04/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25063 0
New Zealand
State/province [1] 25063 0
Taranaki

Funding & Sponsors
Funding source category [1] 310831 0
University
Name [1] 310831 0
Auckland University of Technology
Country [1] 310831 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive, Northcote, Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 312082 0
Charities/Societies/Foundations
Name [1] 312082 0
Centre for Chiropractic Research
Address [1] 312082 0
6 Harrison Road, Mount Wellington, Auckland 1060
Country [1] 312082 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310395 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310395 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 310395 0
New Zealand
Date submitted for ethics approval [1] 310395 0
06/06/2022
Approval date [1] 310395 0
11/08/2022
Ethics approval number [1] 310395 0
2022 EXP 11873

Summary
Brief summary
The aim of this project is to test the feasibility of a novel randomised control trial (RCT) protocol involving a six-week pragmatic chiropractic intervention. The secondary aim is to determine the most appropriate and responsive ANS outcome measures and necessary sample size for a fully powered future pragmatic RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117510 0
Miss Marie Brunsart
Address 117510 0
Coastal Chiropractic
11/4 Egmont Street
New Plymouth 4310
Country 117510 0
New Zealand
Phone 117510 0
+642102680709
Fax 117510 0
Email 117510 0
[email protected]
Contact person for public queries
Name 117511 0
Miss Marie Brunsart
Address 117511 0
Coastal Chiropractic
11/4 Egmont Street
New Plymouth 4310
Country 117511 0
New Zealand
Phone 117511 0
+642102680709
Fax 117511 0
Email 117511 0
[email protected]
Contact person for scientific queries
Name 117512 0
Dr Sharon Olsen
Address 117512 0
Auckland University of Technology
90 Akoranga Drive, Northcote, Auckland 0627
Country 117512 0
New Zealand
Phone 117512 0
+64 9 921 9999 8611
Fax 117512 0
Email 117512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.